Senior Product Engineer

Danaher Corporation•Westborough, MA

5d•$105,000 - $125,000•Onsite

About The Position

The Senior Product Engineer is responsible for supporting the Cytiva Biotech Product Engineering group in the technical aspects of Cassette Product Life Cycle Management (PLCM), consisting of New Product Introduction (NPI), Sustainment and Process/Product improvements, as required. This position reports to the Sr Manager, Product Engineering and is part of the Product Engineering team located in Westborough, MA and will be an on-site role. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

Requirements

Bachelor’s degree in engineering or equivalent experience and minimum 5 years of relevant experience.
Proficient in risk-based change control activities, assessing product and process changes to ensure compliance, mitigate risk and maintain product quality and supply continuity.
Minimum 2 years of Validation experience: Medical device or Bio-Pharmaceutical Industry preferred.
Experience implementing process validation procedures and techniques, such as IQ, OQ & PQ, process and product FMEA, Value Stream Mapping, Ishikawa diagrams, Pareto analysis, parts and process capability studies.
Generate clear and concise validation documents (Protocols and Reports) for new products, processes and equipment, and Engineering Studies summarizing continuous improvement projects.
Ability to solve complex problems; take a new perspective on existing solutions and exercises judgement based on the analysis of multiple sources of information.

Nice To Haves

Formal training and qualification in Six Sigma techniques and Lean tools.
Leading cross functional teams through local and/or global projects.

Responsibilities

Introduce new Filtration products by coordinating with R&D, Marketing and Manufacturing in accordance with the Stage Gate Process or Redevelopment of existing products post launch based on volume or other needs.
Facilitate critical raw material changes while maintaining product quality & customer supply, internally & externally.
Responsible for managing product changes at resident site to the current portfolio & support products through their lifecycle.
Manage and execute local manufacturing process transfers or capacity expansions in line with Cytiva procedures.
Solve problems by using 6 sigma tools, trend analysis, Design of Experiments, FMEA, process risk assessments, etc.